NCT05497128

Brief Summary

The purpose of this study is to compare the efficiency and safety of ultrahigh-speed cut rate 27-gauge system (27+®GA HYPERVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)) and standard cut rate 27-gauge vitrectomy system (27+®GA Advanced ULTRAVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

August 7, 2022

Last Update Submit

August 11, 2022

Conditions

Macular Disease

Keywords

Macular diseaseVitrectomy

Outcome Measures

Primary Outcomes (1)

  • Efficiency of core vitrectomy

    Time to completion of core vitrectomy

    During the vitrectomy

Secondary Outcomes (4)

  • Intraoperative complications

    During the vitrectomy

  • Postoperative complications

    Postoperative period within 4 months after the vitrectomy

  • Efficiency of peripheral vitrectomy

    During the vitrectomy

  • Efficiency of surgery

    During the surgery

Study Arms (2)

Ultrahigh-speed cut rate 27-gauge system

EXPERIMENTAL

Patients will receive the pars plana vitrectomy in the macular disease with the 27-gauge vitrectomy systems with 20,000 cpm probes.

Device: Ultrahigh-speed cut rate 27-gauge system

Standard cut rate 27-gauge system

ACTIVE COMPARATOR

Patients will receive the pars plana vitrectomy in the macular disease with the 27-gauge vitrectomy systems with 10,000 cpm probes.

Device: Standard cut rate 27-gauge system

Interventions

Ultrahigh-speed cut rate 27-gauge systemDEVICE

The ultrahigh-speed cut rate 27-gauge system (27+®GA HYPERVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA))

Ultrahigh-speed cut rate 27-gauge system
Standard cut rate 27-gauge systemDEVICE

The current standard cut rate 27-gauge vitrectomy system (27+®GA Advanced ULTRAVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA))

Standard cut rate 27-gauge system

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All consecutive eyes requiring macular surgery (i.e. epiretinal membrane, vitreomacular traction etc.) that underwent 27-gauge vitrectomy at Seoul National University Bundang Hospital (SNUBH) from September 2022 to August 2023. Patients will be randomized to receive 27-gauge vitrectomy with 20,000 cpm probes (20K group) or 27-gauge vitrectomy with 10,000 cpm probes (standard group).

You may not qualify if:

  • Previously vitrectomized eye
  • Trauma cases
  • Proliferative diabetic retinopathy with fibrovascular membranes
  • Retinal detachment with proliferative vitreoretinopathy
  • Macular hole
  • Endophthalmitis
  • Inability to consent for procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, 13620, South Korea

Location

Related Publications (3)

  • Reibaldi M, Rizzo S, Avitabile T, Longo A, Toro MD, Viti F, Saitta A, Giovannini A, Mariotti C. Iatrogenic retinal breaks in 25-gauge vitrectomy under air compared with the standard 25-gauge system for macular diseases. Retina. 2014 Aug;34(8):1617-22. doi: 10.1097/IAE.0000000000000112.

    PMID: 24651259BACKGROUND

  • Dugel PU, Abulon DJ, Dimalanta R. Comparison of attraction capabilities associated with high-speed, dual-pneumatic vitrectomy probes. Retina. 2015 May;35(5):915-20. doi: 10.1097/IAE.0000000000000411.

    PMID: 25621945BACKGROUND

  • Mariotti C, Nicolai M, Saitta A, Orsini E, Viti F, Skrami E, Gesuita R, Reibaldi M, Giovannini A. STANDARD CUT RATE 25-GAUGE VITRECTOMY VERSUS ULTRAHIGH-SPEED 25-GAUGE SYSTEM IN CORE VITRECTOMY: A Randomized Clinical Trial. Retina. 2016 Jul;36(7):1271-4. doi: 10.1097/IAE.0000000000000924.

    PMID: 26702843BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Kyu Hyung Park, M.D., Ph.D.

    Seoul National University Bundang Hospital, Seongnam, Gyunggi-do, South Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyu Hyung Park, M.D., Ph.D.

CONTACT

82-31-787-7373jiani4@snu.ac.kr

Se Joon Woo, M.D.

CONTACT

82-31-787-7379sejoon1@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 7, 2022

First Posted

August 11, 2022

Study Start

September 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

August 15, 2022

Record last verified: 2022-08

Locations

KR(1)